Auditing is essential to ensuring quality assurance of drug development. Each audit has a degree of complexity which needs effective project management. With ever increasing pressures to complete the audit promptly and to the appropriate quality standard, the effective use of project management can provide essential tools and techniques to achieve this. Indeed effective project management can be a key factor to successful completion of efficient auditing.
This presentation will provide you with an excellent understanding of project management skills, to apply to auditing in all GXP areas. You will be provided with an integrated project tool kit which can easily be used with your existing or future project management tools used for auditing. This tool kit has been used to significantly improve the successful completion of auditing on time to the right quality standard in many pharmaceutical organisations. The presentation will show you how to use these project management skills to gain the most benefit from them in your auditing activities.
We will discuss the basics of project management, including how you can achieve improved, resource utilization, and more timely audit conclusions of your auditing. You will then apply these techniques to improving productivity in the audit process. Using audit-specific examples, you will learn project planning, scheduling, control, and decision support concepts and methodologies -- the basics of project management. The techniques outlined in this session will significantly improve your productivity in planning and managing all audit projects.
Areas Covered in the Webinar:
Who Will Benefit:
This webinar will provide critical assistance to FDA and EMA regulated companies currently carrying out or preparing to conduct audits for pharmaceutical, biotechnology, and biologics products in paediatrics. It will be relevant to all the GXPs regulated areas: GCP, and GMP.
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Dr Laura Brown is an independent Pharmaceutical QA, Management and Training Consultant, and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has more than 20 years' experience of Quality Assurance and managing international clinical trials including risk identification and management and risk based monitoring. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has consulted with numerous pharmaceutical companies, suppliers to the pharmaceutical industry as well as academic institutions.
Dr Brown has an MBA with specialization in project management including risk management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management covering risk management, and the author of two books on project management including the leading book “Pharmaceutical Project Management” (Gower).